Counterfeit products pose a major threat in many industries, both in the form of public safety as well as pecuniary losses. One industry facing the wide-spread problems of counterfeiting is the pharmaceutical industry. The challenges of controlling counterfeit drugs have increased as pharmaceutical markets become more international. For example, drug manufacturing can involve importing materials from other countries, in addition to distributing finished products across international borders. As a result, additional handlers, repackagers and distributors in a variety of locations are required in the product supply chains, thereby rendering proprietary drugs even more vulnerable to tampering and fraud. These complex supply chains create entry points through which contaminated, adulterated and counterfeit products can infiltrate the drug supply.
Counterfeiting activities in oral pharmaceuticals can take various forms, such as (i) entirely fraudulent products containing no active ingredient, (ii) diluted, generic or insufficient dosages of the active ingredient, contrary to the labeled dosages on the packaging or (iii) substitution of the intended active ingredient with a different or inferior drug to elicit a similar physiological response. In addition, some fraudulent pharmaceuticals contain harmful or toxic ingredients. Counterfeit pharmaceutical products that fail to deliver critical active ingredients, or inflict toxic effects, pose a significant threat to public safety.
There are documented cases of counterfeiters targeting a wide range of prescription and non-prescription products, such as vaccines, cough syrup, anti-malarial drugs, heparin, painkillers, blood thinners, dietary supplements, teething medicines, hypertensive medicines, steroids. Products that are expensive and/or high demand in underdeveloped countries are attractive targets for counterfeiting activity. Counterfeit drugs can lead to illness, increased health risks and in extreme cases involving diethylene glycol (DEG) and melamine, have been fatal.
Governmental regulatory agencies, both in the U.S. and abroad, have struggled to detect, prevent, and address drug contamination and counterfeiting issues. Limited governmental resources and a lack of international consensus have hindered the implementation of global, uniform drug control practices. In order to be effective, agencies need to agree on what constitutes a counterfeit drug, the high-risk proprietary drugs, product traceability and authentication systems and sampling/testing protocols at international borders. Undeveloped and underdeveloped nations are particularly vulnerable to the activities of drug counterfeiters.
The pharmaceutical industry has focused on unique packaging that allow the end users to discern authentic from counterfeit products. These efforts have included barcodes, holographic labels, laser encrypted labels, color shifting security ink, and DNA reagent markers. Ideally, these packaging security features should be easily identifiable, yet difficult to duplicate. Unfortunately, over time, increasingly sophisticated forgery efforts have adapted many of these package security measures.
In addition to marking drug packaging the actual drugs can be marked with a security feature to authenticate the product. This direct marking approach has various benefits. If a legitimate drug manufacturer is able to mark his pharmaceutical product with an identifying physical tag at the time of manufacture, this will enable a health professional to determine if the drug is genuine at any point post-production. Such drug “tracers” are called tags, microtags, taggants, markers and/or microparticles. Detection, or lack thereof, of these tracers in a pharamacutical product will ideally serve as a marker to indicate drug authenticity or drug fraudulence, respectively.
The need for security control measures to thwart counterfeiting and product tampering extend to a variety of industries, including various foods and other types of consumables. Well known examples of counterfeiting and tampering exist in powdered and liquid baby formula, animal feed, pet foods, cigarettes, plastics and replacement airbags. There is also a need for tracer particles in forensic applications, such as coding for the source of explosive materials.
Various tagging technologies for the authentication of marked goods have been proposed, including systems for drug marking and drug tracing. Tracers have also been described for coding the source of dynamite and black powder. However, these proposed systems have various drawbacks. Limitations of these existing tracer systems include the large sizes of the tracer particles, making them unsuitable in applications such as coding human pharmaceuticals. Other significant limitations in the tracer particles art include particles that are not suitable for human or animal ingestion, tracers that are expensive to produce, and the analytical procedures to detect and/or quantify such tracers either have not been developed, are expensive, are time consuming, are not readily portable, or require materials or reagents that are not readily available.
What is needed in the art are improved tracer particles and associated techniques for monitoring counterfeit/fraudulent products, or products that have been subject to tampering. Ideally, these improved systems will permit cost-effective sampling and testing for product integrity. Also what is needed in the art are tracers that are suitable for ingestion.
What is needed in the art are improved tracer particles that can be added directly to an oral pharmaceutical formulation at the time of manufacture, in parallel with the active ingredient. This type of drug tracer should be undetectable or sufficiently complex to thwart counterfeiters from detecting or reproducing the tracer particles. Ideally, methods for detection of the tracer in the manufactured product should be non-complex and use equipment that is readily available and ideally also portable. Such drug tracers will permit determination of pharmaceutical authenticity anywhere along the post-production stream of commerce. Optionally, this type of authenticity control can be done covertly by the drug manufacturer.
The present invention, in its many embodiments, provides compositions and methods for product security that overcome challenges in the industry, and provide many benefits previously unrealized in other types of security products. In addition, still further benefits flow from the invention described herein, as will be apparent upon reading the present disclosure.